Recruiting

Radiotherapy

Sponsor:

AHS Cancer Control Alberta

Code:

NCT04104945

Conditions

Squamous Cell Carcinoma of the Oropharynx

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

De-intensified chemoradiotherapy

Study Details

Brief summary:

Volume and Dose De-Intensified Radiotherapy for p16+ Squamous Cell Carcinoma of the Oropharynx: A Multi-Centre, Single Arm Prospective Cohort Study

Conditions

Squamous Cell Carcinoma of the Oropharynx

Study ID

NCT04104945

Start date

Jan 12, 2021

Status verified date

Mar, 2024

Completion date

Oct 21, 2028

Anticipated

Primary completion date

Oct 21, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 18 or older

  • Provide informed consent
  • ECOG performance status 0-2
  • Histologically confirmed squamous cell carcinoma
  • p16-positive tumor, as determined by immunohistochemistry at local hospital
  • Primary tumor site in the oropharynx (includes tonsil, soft palate, base of tongue, walls of oropharynx)
  • Eligible for curative intent treatment.
  • Smokers and non-smokers are included
  • Tumor stage (AJCC 8th edition): T1 to T3
  • Nodal stage (AJCC 8th edition): N1 to N2
  • Adequate bone marrow function, hepatic, and renal function for chemotherapy (Hemoglobin > 80 g/L; Absolute neutrophil count >1.5x109 /L, platelets > 100 x109/L; Bilirubin < 35 umol/L; AST or ALT < 3 x the upper limit of normal; serum creatinine < 130 umol/L or creatinine clearance ≥ 50 ml/min)

Exclusion Criteria:

  • - Clinical, radiologic or pathologic Ib nodal involvement (including invasion into submandibular gland)
  • Primary cancer with extension and involvement of the oral cavity
  • Metastatic disease
  • Contraindications to radiotherapy or chemotherapy
  • Prior history of head and neck cancer within 5 years
  • Prior head and neck radiation at any time
  • Inability to attend full course of radiotherapy or follow-up visits
  • Pregnant or lactating women

Study Design

Enrollment

32 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: De-intensified chemoradiotherapy

Radiotherapy to a dose of 60 Gy to the primary tumour and involved lymph nodes and 54 Gy to subclinical regions at risk in 30 fractions. Reduced volume of elective nodal radiation.

Interventions

De-intensified chemoradiotherapy

Radiotherapy to a dose of 60 Gy to the primary tumour and involved lymph nodes and 54 Gy to subclinical regions at risk in 30 fractions. Reduced volume of elective nodal radiation.

Primary outcome measure

  • Xerostomia-related quality of life [ Time Frame: 12 months ]
  • Toxicity Criteria for Adverse Events [ Time Frame: Baseline to 5 years ]

Central Contacts and Locations

Central contacts

Harvey Quon, MD

403-521-3619harvey.quon@ahs.ca

Kelsey Meyer

Kelsey.Meyer@ahs.ca

Locations

Tom Baker Cancer Centre

Recruiting

Calgary, Alberta, Canada

Contacts

Harvey Quon, MD

Harvey.Quon@ahs.ca

Kelsey Meyer

Kelsey.Meyer@ahs.ca

More Information

Sponsor

AHS Cancer Control Alberta

Last update posted

Mar 4, 2024

Last verified

Mar, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by AHS Cancer Control Alberta on 2024-03-04.